Bioprocess Manufacturing Technician

Job Description

Job Description Title: Bioprocess Manufacturing Technician
Location: Oceanside, CA 92056 (Onsite)
Duration: 12 Months Contract (high possibility of extension)
Potential to Convert to FTE: Yes
Description:

• Responsible for producing medicine in a highly automated and controlled environment.
• Each product has a specific recipe; you will follow this recipe, along with the standard operating procedures, to operate the production equipment across various areas, including raw material dispensing/aliquoting, cell culture, and purification.
• You will maintain records and follow all the steps necessary to comply with regulatory requirements within a current Good Manufacturing Practices (cGMP) environment.
• We have both Stainless Steel and Single-Use Manufacturing facilities that are supported by Production Services.

There are 3 main production areas within manufacturing:
Production Services - Responsible for weighing and aliquoting of raw materials and small-scale solution prep. Also responsible for washing, autoclaving, and preparing small equipment parts and assemblies. Responsible for environmental monitoring of the facility.
Upstream Manufacturing - Responsible for cell growth from inoculation in spinner flasks through large-scale bioreactors and the harvesting of cell culture via centrifugation and depth filtration.
Downstream Manufacturing - Responsible for the purification of cellular harvest utilizing chromatography and reformulation techniques, as well as preparation of product for shipping to final fill/finish sites.

• As a new member of the team, you'll typically be assigned to one of the three production areas.
• This will allow you to build capabilities and work on increasingly complex technical assignments, with the potential to rotate into future production areas as you gain experience.

Job Responsibilities:

• Safety is paramount to both our employees and our patients, and is therefore at the core of all job responsibilities.
• This includes complying with all safety requirements, cGMP, Standard Operating Procedures (SOP), and manufacturing documentation.
• You must immediately report any and all safety and environmental incidents, including injuries, illness, near misses, and safety suggestions.

Additional responsibilities may include:

• Utilizing automated systems to operate, clean, and sterilize production equipment.
• Operating small-scale cell culture areas and systems by using aseptic techniques, maintaining cell banks, and performing general seed lab operations.
• Operating fermenters, centrifuges, other harvest systems, and protein purification units.
• Operating and cleaning fixed tank and filtration systems.
• Operating large-scale column chromatography systems.
• Preparing solutions required for the production process (media and buffer make-up).
• Cleaning, assembling, and sterilizing equipment for production by operating glass washers and autoclaves.
• Executing environmental monitoring throughout the facility

Qualifications / Requirements:

• Proficiency in the English language- reading, writing, and communication.
• Must be computer literate due to the extensive automation used in our facility, with experience with Microsoft and Google platforms.
• Must be able to work all shifts, required overtime as needed, and stand for extended periods of time.
• Our facility is expansive - you may climb multiple flights of stairs daily
• Lifting up to 25 lbs is required.
• The cleanroom environment requires gowning in the form of cleanroom scrubs, bunny suits, gloves, hair covers, safety glasses, and steel toe boots be worn.
• No makeup or jewelry can be worn when working in the clean room environment. Personal electronic devices (e.g. cell phones) are not permitted in cleanrooms without formal approval due to health authority regulation.
• You may work with hazardous materials and chemicals
• Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job.

Educational Requirements

• High school diploma or equivalent

Preferred:

• Degree in Life Sciences/Engineering, Associate's or Biotech certificate from an approved program

Shift Details:
We have a variety of 12- and 10-hour shifts to support our 24x7 facility operations. Staff working over 8 hours in a day will be paid overtime in accordance with local and state laws. In addition, staff working swing or night shifts will be paid a shift differential. While we are occasionally able to accommodate shift requests, candidates with open availability will be given priority consideration as we are not able to guarantee shift placement.

Candidates must be able to work any of the following manufacturing shifts:
12 hr Day Shift, 6:00 am 7:00 pm,
Work: Sunday - Tuesday, plus every other Wednesday
Work: Wednesday Friday, plus every other Saturday
10 hr Day Shift, 6:00 am 4:30 pm
Sunday - Wednesday
Wednesday - Saturday
10 hr Swing Shift, 3:30 pm -2:00 am
Sunday - Wednesday
Wednesday - Saturday
12 hr Night Shift, 6:00 pm -7:00 am
Sunday-Tuesday plus every other Saturday
Wednesday Friday, plus every other Saturday
Onboarding will consist of a 3-4 week schedule of Monday through Friday, 8 am - 5 pm, followed by on-the-job training on the respective shift schedule.

To learn more about the manufacturing process, please watch this video: https://www.youtube.com/watch?v=sxvJatvqBVE
Please note: We currently do not sponsor work visas for this position or offer relocation assistance.

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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

Company DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Company Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA